- Induction: All patients receive 4 courses of cytoreductive chemotherapy comprising an
anthracycline-containing combination. Patients not achieving complete remission after 4
courses receive 2 additional courses of induction chemotherapy. Patients without at
least a partial response after 6 courses discontinue treatment; those with at least a
partial response proceed to arm I or II.

Arm I

- Consolidation: Patients achieving complete or partial remission after 4-6 courses of
induction therapy begin intensified chemotherapy within 6 weeks. Patients receive oral
dexamethasone daily on days 1-10, carmustine IV on day 2, melphalan IV on day 3,
etoposide IV daily and cytarabine IV twice a day on days 4-7. Patients also receive
filgrastim (G-CSF) beginning on day 11 and continuing until peripheral blood stem cells
(PBSC) are harvested.

- Within 4-6 weeks after PBSC harvest, patients undergo myeloablative radiochemotherapy
comprising radiotherapy on days -6 to -4 and cyclophosphamide IV on days -3 to -2.
Patients then undergo PBSC transplantation on day 0.

- Maintenance: Within 4 weeks after arm II consolidation, patients receive interferon
alfa subcutaneously (SC) 3 days a week in the absence of unacceptable toxicity or
disease progression or relapse. Patients who experience first relapse or progression
during maintenance therapy may receive intensified chemotherapy as in arm I.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 210 patients will be accrued for this study within 5 years.

NCT ID:

Start Date:

Completion Date:

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